BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI SPA

Overview

BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI SPA is an active pharmaceutical ingredient (API) supplier with 4 active FDA Type II Drug Master Files, covering INDAPAMIDE; PRAZOSIN HYDROCHLORIDE BULK SUBSTANCE; TERAZOSIN HCL. 2H2O; TORSEMIDE (MOD 1) BULK SUBSTANCE.

API / Drug Master Files

BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI SPA holds 4 active (5 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

  • TORSEMIDE (MOD 1) BULK SUBSTANCEActive2006-03-08
  • PRAZOSIN HYDROCHLORIDE BULK SUBSTANCEActive2001-02-28
  • TERAZOSIN HCL. 2H2OActive2000-06-12
  • INDAPAMIDEActive1991-03-28
  • TERAZOSIN HCL 2H20Inactive1997-12-22

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI SPA in our records. PharmaTek screens the full directory against live FDA enforcement data.

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